The Effect of Probiotic and Zinc Supplementation on the Common Cold

• Sponsor: Lund University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04672850
• Collaborator: Coradil AB (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.1
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

The purpose with this study is to investigate the preventative effect of a supplement containing a combination of probiotic bacteria and fungi as well as zinc on the common cold. The hypothesis is that it will shorten the duration, alleviate the severity of symptoms or even decrease the number of infectons during the intervention period. This study is a randomzed placebo controlled human study were healthy adults will consume the supplement for three months.

Condition or Disease	Intervention/Treatment	Phase
Common Cold	Dietary Supplement: Probiotic; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double-blinded
• Primary Purpose: Prevention
• Official Title: The Effect of Probiotic and Zinc Supplementation on the Common Cold in Healthy Adults
• Actual Study Start Date: Jan 27, 2021
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Rice flour	Dietary Supplement: Placebo; The participants will consume 2 capsules daily for three months
Active Comparator: Probiotic Probiotic bacteria, yeast, zinc and rice brand	Dietary Supplement: Probiotic; The participants will consume 2 capsules daily for three months

Outcome Measures

Primary Outcome Measures

1. Symptoms severity [Three months]

   Decrease in the severity of symptoms will be determined using a common cold questionnaire.

Secondary Outcome Measures

1. Composition of gut and oral microbiome [Three months]

   Change in gut and oral microbiome will be measured using 16SrRNA and 18SrRNA sequencing

2. IgA [Three months]

   Changes in levels of IgA in saliva and/or feces will be measured using ELISA

3. Duration of symptoms [Three months]

   Decrease in duration of cold will be determined using a common cold questionnaire

4. Number of colds [Three months]

   Decrease in number of colds will be determined using a common cold questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

• Diagnosed gastrointestinal disorders

• Autoimmune diseases or immuno compromized

• Antibiotic treatment in the last month

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lunds universitet	Lund		Sweden

Sponsors and Collaborators

• Lund University
• Coradil AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Åsa Håkansson, Assoc. Prof., Lund University
• ClinicalTrials.gov Identifier: NCT04672850
• Other Study ID Numbers: Prozicold
• First Posted: Dec 17, 2020
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Common Cold

Study Results

No Results Posted as of Apr 12, 2022